Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Merit Medical Australia Pty Ltd - StabiliT VP Vertebroplasty System - Orthopaedic cement
ARTG entry for
Medical Device Included Class IIb
Merit Medical Australia Pty Ltd
63 Wells Road,Chelsea Heights, VIC, 3196
ARTG Start Date
Medical Device Class IIb
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Merit Medical Systems Inc
1600 West Merit Parkway
South Jordan, UTAH, 84095
United States Of America
1. StabiliT VP Vertebroplasty System - Orthopaedic cement preparation/delivery kit
Medical device system
45253 Orthopaedic cement preparation/delivery kit
The StabiliT VP Vertebroplasty System is intended for percutaneous delivery of StabiliT Bone Cement.
The StabiliT Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a
vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from
osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
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Produced at 02.11.2019 at 05:10:17 AEDT
This is not an ARTG Certificate document.
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